FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594050908
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP21KAAR4
Catalog number
SOP21KAAR4
Device description
ATHENS KNEE ARTHROSCOPY
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594050908PackageGS11In Commercial Distribution
10195594050900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559405090850195594050908
1019559405090010195594050900

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286306CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956423633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956461048CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956498433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956504554CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956512023CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956517363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956519299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956530713CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956536784CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956538801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956539594CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956541184CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956542723CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956543959CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545663CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545731CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956546615CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548947CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956550537CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956551671CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956552050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956554221CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956556584CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956557536CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956558113CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956559981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26